Kornimate/medical-research-clean huggingface dataset:
cosmetic outcomes of absorbable versus non-absorbable sutures in pediatric facial lacerations

Conditions: Lacerations; Wounds

Summary: our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations.

the standard method of repair for facial lacerations is to close such wounds with non-absorbable sutures. recently, topical skin adhesives such as n-butyl-2-cyanoacrylate and 2-octyl cyanoacrylate have been used more frequently as these have been shown to be a faster and less painful way to close superficial facial lacerations. however, lacerations that are deeper, gaping or occurring along lines of excessive tension, such as the chin, still need sutures for repair. non-absorbable sutures have to be taken out at 4-7 days. this involves another physician visit, parental absence from work, and children who need to be taken out of school or daycare for a simple suture removal. in part iof the study, we were able to demonstrate non-inferiority of absorbable sutures to nylon sutures. however, we purposely removed all remaining absorbable sutures on the 5-7 day follow-up visit. in part ii, we will allow the absorbable sutures to dissolve on their own. we will again assess long term cosmetic outcomes, as well parental satisfaction, and short and long-term complication rates at 3 months.

Eligibility criteria:
inclusion criteria: * clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair exclusion criteria: * pregnancy * bleeding * renal * endocrine problems * dirty wounds * irregular wounds

Keywords: laceration wound management absorbable sutures cosmetic outcomes
mindfulness-based substance use prevention (minds-up)

Conditions: Substance Use

Summary: the goal of this clinical trial is to test the feasibility, behavioral/neural mechanisms, and preliminary efficacy of "mindfulness-based substance use prevention program," or "minds-up", a novel substance use prevention meditation intervention for children and adolescents between the ages of 10 and 14. the main questions it aims to answer are: 1. is minds-up feasible and what is its preliminary efficacy? 2. are mri protocol and procedures feasible? an additional exploratory question is: are there neural and psychopathological mechanisms through which minds-up might work? researchers will compare sport - prevention plus wellness (ppw) (an evidence based substance use prevention program) to sport - prevention plus wellness + minds-up to examine the preliminary efficacy of minds-up. participants will * take assessment #1 * have 2 mris and take minds-up, just take minds-up or have a delayed start * take assessment #2 * take ppw, a single remote and research assistant-delivered 45-minute session * take assessment #3 * take assessment #4


Eligibility criteria:
inclusion criteria: * youth is ages 10-14 years on the day of screening \[i.e., does not turn 15 before or on the day of screening\] * access to a smart phone, tablet, or computer with wi-fi * english-speaking exclusion criteria: * has been diagnosed with or received treatment for one of the following mental health problems: depression, bipolar disorder, schizophrenia, autism spectrum disorder, intellectual disability, or substance use disorder. * youth is actively involved in another boricua youth study (bys) * youth's sibling is or has previously been enrolled in minds-up.
effect of starter formula on infection prevention

Conditions: Gastro-intestinal Infections; Infections With Fever

Summary: the aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.


Eligibility criteria:
inclusion criteria: * healthy newborn infant * full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation) * age of infant is ≤ 13 days at the time of enrollment * birth weight ≥ 2500g and ≤ 4500g * for the ff groups: the infant's mother has elected not to breastfeed * for the bf group: the infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age * having obtained his/her legal representative's informed consent exclusion criteria: * congenital illness or malformation that may affect normal growth (especially immunodeficiencies) * significant pre-natal and/or post-natal diseases * perinatal antibiotic or infants on antibiotics at the time of inclusion * infants whose mother has had an acute infection during the last month of pregnancy * re-hospitalisation for more than 2 days in the first 14 days of life (exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study) * receiving infant formula containing probiotics and/or prebiotics at the time of enrollment * newborn whose parents / caregivers cannot be expected to comply with treatment * newborn currently participating in another interventional clinical trial
fascial closure and post-caesarean pain

Conditions: Pregnancy Related; Cesarean Section; Post-operative Pain; Fascial Closure; Surgical Technique

Summary: this study will evaluate post-operative pain in patients undergoing elective caesarean sections based on the method of fascial closure. patients will be randomised into one of three groups based upon the method of fascial closure and will be followed up over a 10 week period evaluating analgesia use in the acute setting, and also following up with pain scores using a visual analogue score throughout the follow-up period.

participants will be approached prior to their elective caesarean section to be consented. if they agree to be a part of the study, they will then be randomised into one of three groups based upon the method of fascial closure after delivery of the foetus and closure of the hysterotomy site: 1. fascia sutured with #1 polysorb braided absorbable suture, with the knot being superficial to the fascia, starting at the left angle of the fascial incision and closed in a continuous fashion. the contralateral angle is grasped with a kocher clamp and the suture is then tied behind the angle ensuring adequate closure. 2. fascia sutured using #1 polysorb braided absorbable suture with a superficial knot, starting at the left angle and closed in a continuous fashion until the suture is above the right rectus abdominis muscle belly. a second #1 polysorb braided absorbable suture is tied behind the right angle with a superficial knot and run across in a continuous fashion to meet the opposing suture which are then tied together. 3. fascia sutured using #1 polysorb braided absorbable suture with a buried knot below the fascia starting at the left angle and closed in a continuous fashion until the suture overlies the right rectus abdominis muscle belly. a second #1 polysorb braided absorbable suture is then tied behind the right angle with a buried knot below the fascia and run across in a continuous fashion to meet the opposing suture which are then tied together. the remainder of the caesarean section is completed in the standard fashion. subsequent to this, patients are followed up with a modified brief pain inventory on post-operative day #1, day #7, day #14, day #42 and day #70 to evaluate their pain in the post-operative period. in addition, whilst being inpatients, participant's analgesia use is evaluated using the medication administration record within the unit.

Eligibility criteria:
inclusion criteria: * women with singleton pregnancy undergoing elective lower segment caesarean section via a pfannenstiel incision. * caesarean section done via regional anaesthesia (i.e. spinal regional anaesthesia, epidural anaesthesia, combo-spinal+epidural) exclusion criteria: * multiple pregnancy * general anaesthesia * caesarean section through laparotomy incision * history of chronic pain

Keywords: pregnancy-related cesarean section post-operative pain fascial closure surgical technique
the influence of red grape cells on blood pressure vascular function in people with hypertension

Conditions: Hypertension

Summary: the study hypothesis is that 3 months daily supplementation of rgc will effect blood pressure and vascular function. this will be a single-center, double-blind, random, parallel controlled study. study population will include 60 subjects, who will be divided randomly into three groups. the first group will get rgc 200mg, the second group will get rgc 400mg, and the third group will get 200mg placebo.


Eligibility criteria:
inclusion criteria: * age 35-70 * bmi \< 40.0 kg/m2 * blood pressure: sys. ≤154 mmhg, dia. ≤93 mmhg. exclusion criteria: * breastfeeding or pregnancy. * milk allergy - the substance may contain traces of milk protein (casein). * taking anti-hypertensive medications. * taking antioxidant food supplements, excluding probiotic agents and fibers (taken for less than two weeks before beginning the study). * subjects suffering from any of the following conditions: cardiovascular disorders, renal disorders, intestinal disorders, hepatic disease, malignant or autoimmune diseases or other metabolic diseases. * a subject whose baseline blood tests indicate abnormalities in hepatic or renal function, thyroid function or blood count. * unusual eating habits. * the subject is in the process of active weight loss / gain. * addiction to drugs / alcohol. * medically documented psychiatric problems or neurological disorders. * smokers. (subjects who quit smoking more than two years ago may be included in the study). * systolic blood pressure above 154 mmhg. * diastolic blood pressure above 93 mmhg. * taking phosphodiesterase 5 inhibitors for the treatment of erectile dysfunction (viagra, cialis, etc.).
prevention of perinatal sepsis (pops): evaluation of chlorhexidine wipes of birth canal and newborn

Conditions: Infant, Newborn, Diseases; Sepsis; Puerperal Infection

Summary: the purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth. if effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.

we are conducting a randomized, controlled clinical trial in soweto, south africa to evaluate the efficacy of 0.5% chlorhexidine wipes of the birth canal during labour and of the infant at birth in reducing 1) vertical transmission of leading pathogenic bacteria from mother to child during labour and delivery, and 2) incidence of neonatal sepsis and maternal peripartum infection, in comparison to external genitalia sterile water wipes. in conjunction with this, we will compare vaginal carriage of bacteria commonly associated with neonatal sepsis and maternal peripartum infection among hiv-infected and non-infected pregnant women who deliver at the only public hospital in soweto, and will characterize the burden of disease and risk factors for maternal peripartum infection and serious neonatal infections in this population by conducting active prospective surveillance.

Eligibility criteria:
inclusion criteria: * pregnant * plan to deliver at chris hani baragwanath hospital or one of its satellite clinics * plan to remain in soweto for at least two months after delivery * are able to understand and give informed consent * are at least 15 years old at time of registration exclusion criteria: * planned delivery by caesarean section * antenatal ultrasound revealing major fetal congenital anomalies * have known or suspected condition in which vaginal exams are contraindicated, e.g. placenta previa * have a history of allergic reaction to any topical antiseptic solution * present to labour ward with infant born before arrival * present to labour ward with significant vaginal bleeding during labour * present with known intrauterine fetal death prior to randomization * subject noted to be in full cervical dilatation or have baby's head on perineum * infant noted to be in face presentation on first vaginal examination * noted to have genital ulcers present on first vaginal examination

Keywords: chlorhexidine prevention neonatal sepsis peripartum infections
quetiapine extended release (xr) for the treatment of menopausal depression

Conditions: Major Depressive Disorder; Insomnia; Hot Flashes

Summary: the study was designed to examine the efficacy and tolerability of quetiapine xr for the treatment of women who suffer from depression in the context of the menopausal transition and postmenopausal years. besides the improvement of depressive symptoms, the investigators are interested in examining the impact of this medication on vasomotor symptoms (hot flashes, night sweats), sleep and overall quality of life.

the menopause transition (or perimenopause) and the early postmenopausal years are marked by intense hormone fluctuations; hormone changes are frequently accompanied by the occurrence hot flashes, night sweats and sleep disturbance. recent epidemiologic studies also demonstrate that perimenopause is a period of greater risk for the development of depressive symptoms. to date, serotonergic antidepressants such as paroxetine and escitalopram have shown to be efficacious for the treatment of women with depression and menopause-related symptoms. we hypothesize that the use of quetiapine for this sub-population will alleviate symptoms of depression; we also anticipate that its use may enhance quality of life and improve vasomotor symptoms - the latter possibly due to quetiapine's effect on 5ht receptors and/or due to its sleep-promoting properties (e.g., by increasing the duration of total sleep time \[tst\], enhancing sleep efficiency, and decreasing the number of awakenings due to hot flashes).

Eligibility criteria:
inclusion criteria: * women 40 to 60 years * diagnosis of mdd * perimenopausal or postmenopausal exclusion criteria: * using hrt * using psychotropic medications * other dsm-iv axis i diagnoses other than mdd

Keywords: major depressive disorder insomnia hot flashes menopause quetiapine
pilot study on immunotherapy for the treatment of persistant peanut allergy

Conditions: Food Allergy; Peanut Allergy

Summary: the purpose of this trial is to assess the safety and efficacy of peanut immunotherapy in children and adults with peanut allergy. participants will receive immunotherapy with peanut every 2 weeks for a period of 3 months.


Eligibility criteria:
inclusion criteria: 1. informed consent as documented by signature. 2. male or female subjects 12 to 45 years old at screening visit. 3. patients with convincing history of ige-mediated systemic allergic reaction after consumption of peanut, and specific ige above 95% positive predictive value: a. peanut ≥ 15ku/l or ara h 2 ≥ 5u/l 4. patients without a convincing history of ige-mediated systemic allergic reaction (for example only oral symptoms) after consumption of peanuts but with clear evidence of sensitization (spt \> 3 mm and/or positive specific ige (\> 0.1ku/l) and a positive standardized food challenge to peanut between v0 and v1. exclusion criteria: 1. subjects with a history of severe anaphylaxis to the incriminated food with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence). 2. subjects with a history of systemic reaction to peanutskin prick test with commercial extract. 3. uncontrolled asthma (forced expiratory volume at one second (fev1) \<70% of predicted value), active eosinophilic oesophagitis or any condition deemed incompatible by the investigator. 4. known or suspected systemic mastocytosis. 5. subject currently under allergen immunotherapy. 6. subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion. 7. participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study. 8. use of immunosuppression or immunomodulatory drug (including anti-ige or anti-tumor necrosis factor (tnf)) within 1 year prior to inclusion in study. 9. relative counter-indication or inability to use epinephrine auto-injector. 10. subjects receiving beta-blockers or angiotensin converting-enzyme (ace) inhibitors. 11. women who are pregnant or breast feeding. 12. intention to become pregnant during the course of the study, or inadequate contraceptive measures for women of child-bearing age (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). 13. other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.). 14. diseases with a contraindication for the use of adrenalin (e.g. hyperthyroidism, glaucoma). 15. known or suspected non-compliance, drug or alcohol abuse. 16. inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. 17. patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators
early weight bearing for ankle fractures

Conditions: Broken Ankle

Summary: the purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational bimalleolar and trimalleolar (ao/ota classification of 44a and 44b) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.


Eligibility criteria:
inclusion criteria: * men and women ages of 18 and up * closed, low-energy bimalleolar and trimalleolar rotational ankle fractures * orthopaedic trauma association (ota) classification of 44a and 44b * english speaking * able and willing to consent exclusion criteria: * open fractures * ota classification of 43 and 44c * patients with diabetes mellitus * no other lower extremity injuries that would affect functional outcomes * previous use of walking aides * patients with paralysis or hemiplegia * ankle fractures requiring syndesmotic repair * ankle fractures requiring fixation of the posterior malleolar * associated neurovascular injury * problems maintaining follow up (homeless or not willing to return for follow up) * pathological fractures * prisoners * patients not allowed to bear weight before the 6 week post-operative follow up visit
the smart-lv pilot study

Conditions: Left Ventricular Systolic Dysfunction

Summary: the goal of this pilot study is to evaluate the prospective performance of an image-based, smartphone-adaptable artificial intelligence electrocardiogram (ai-ecg) strategy to predict and detect left ventricular systolic dysfunction (lvsd) in a real-world setting.

the smart-lv pilot study will be a prospective cohort study in outpatient clinics at the yale new haven hospital. participants who have undergone a 12-lead electrocardiogram (ecgs) with either a high (≥80%) or low (\<10%) probability of lvsd on ai-ecg algorithm, but without an echocardiogram done in the clinical setting for at least 90 days after the ecg, will be identified by electronic health record (ehr) and invited for a limited echocardiogram/cardiac ultrasonogram for assessing lv ejection fraction. the goal of the study is to evaluate the feasibility of recruiting patients and performing the study after pursuing a screening on 12-lead ecgs. the procedure currently used for detection of lvsd, echocardiograms, are inaccessible and expensive. therefore, while ai-ecg-based algorithms using a smartphone- or web-based application can broaden access to screening, a thorough evaluation for this indication is needed before clinical adoption. the investigators intend to use the results as pilot data for sample size and drop-off rate estimation for a subsequent larger prospective cohort study aimed at validating the performance characteristics of the model in a screening setting. the validation of this accessible ecg-based screening strategy, that can be directly used by clinicians using a smartphone or web-based application, can transform the early identification of lvsd before the development of symptoms, thereby allowing broader utilization of evidence-based therapies to prevent symptomatic heart failure and premature death.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form. * stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: * patients who have undergone a prior echocardiogram. * patients with a prior diagnosis of left ventricular dysfunction, based on a documented low ejection fraction (ef) in the medical record. * patients with an intermediate predicted probability of low ef (10 to 80%) * patients with a prior diagnosis of heart failure as determined by international classification of diseases-10 diagnosis code for heart failure. * research opt-out patients
use of a taurolidine containing antimicrobial wash to reduce prosthetic device infection after trauma surgery

Conditions: Osteosynthesis; Infection Prevention

Summary: a taurolidine-based antimicrobial solution, was evaluated for its safety and efficacy in preventing infections associated with prosthetic materials, such as joint replacements, plates, nails, and screws. this prospective observational study compared taurolidine to infection rates from scientific literature.

during any invasive procedure involving prosthetic materials at the corresponding author's institution, the surgical site was irrigated, and all accessible hardware (including nails, screws, plates, and prosthetic joint replacement therapy devices) was wiped with taurolidine. only procedures performed between 01/01/2022 and 01/10/2023, where taurolidine was applied, were included in the analysis. patients who underwent multiple procedures were censored for the last treatment group and reassigned at the next procedure. preoperative antibiotic prophylaxis was administered according to institutional guidelines, and no additional intraoperative antimicrobial agents were used aside from taurolidine. the primary endpoint was the occurrence of a major infection within three months post-procedure, defined as: 1. infection necessitating revision procedure, 2. a requirement for prolonged antibiotic therapy, or 3. infection leading to mortality. secondary endpoints included infections beyond three months, adverse events potentially related to the antimicrobial solution, procedural complications (i.e., hematoma formation, nerval lesions, etc), and mortality during all follow-up.

Eligibility criteria:
inclusion criteria: * requires osteosynthesis with placement of prosthetic materials exclusion criteria: * minor, can't or won't sign pic, can't undergo surgical procedure